Dutasteride Teva 0,5 mg, zachte capsules

Dutasteride Teva is used to treat men with an enlarged prostate ( benign prostatic hyperplasia)- a non- cancerous growth of the prostate gland, caused by producing too much of a hormone called dihydrotestosterone.

The active ingredient is dutasteride. Dutasteride Teva belongs to a group of medicines called 5-alpha reductase inhibitors.

As the prostate grows, it can lead to urinary problems, such as difficulty in passing urine and a need to go to the toilet frequently. It can also cause the flow of the urine to be slower and less forceful. If left untreated, there is a risk that your urine flow will be completely blocked (acute urinary retention). This requires immediate medical treatment. In some situations surgery is necessary to remove or reduce the size of the prostate gland. Dutasteride Teva lowers the production of dihydrotestosterone, which helps to shrink the prostate and relieve the symptoms.

Dutasteride Teva may also be used with another medicine called tamsulosin (used to treat the symptoms of an enlarged prostate).

Do not take Dutasteride Teva

• If you are allergic (hypersensitive) to dutasteride, 5-alpha reductase inhibitors or any of the other ingredients of Dutaseride Teva,
• If you have a severe liver disease.

Inform your doctor if you think any of these apply to you.

This medicine is for men only. It must not be used by women, children or adolescents.

Take special care with Dutasteride Teva

REG0048149

Version 2.5

Approved

Page 2 of 7

• In some clinical studies, more patients taking dutasteride and another medicine called an alpha- blocker,like tamsulosin experienced heart failure than patients taking only dutasteride or only an alpha blocker. Heart failure means your heart does not pump blood as well as it should.
• Your doctor must be aware about your liver problems before using this medicine. If you have had any illness affecting your liver, you may need regular monitoring while you are taking Dutasteride Teva.
• Women, children and adolescents must not handle leaking Dutasteride Teva capsules, because the active ingredient can be absorbed through the skin. Wash the affected area immediately with soap and water if there is any contact with the skin.
• Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking Dutasteride . If your partner is or may be pregnant, you must avoid exposing her to your semen as dutasteride may affect the normal development of a male baby. Dutasteride has been shown to decrease sperm count, semen volume and sperm motility. This could reduce your fertility.
• Dutasteride Teva affects a blood test for PSA (prostate-specific antigen), which is sometimes used to detect prostate cancer. Your doctor should be aware of this effect and can still use the test to detect

prostate cancer. If you are having a blood test for PSA, tell your doctor that you are taking Dutasteride Teva. Men taking Dutasteride Teva should have their PSA tested regularly.

• Dutasteride Teva may cause breast enlargement and tenderness. If this becomes troublesome, or if you notice breast lumps or nipple discharge you should talk to your doctor about these changes as these may be signs of a serious condition, such as breast cancer.
• In a clinical study of men at increased risk of prostrate cancer, men taking dutasteride had a serious form of prostrate cancer more often than men who did not take dutasteride. The effect of dutasteride on this serious form of prostrate cancer is not clear.

Contact your doctor or pharmacist if you have any questions about taking Dutasteride Teva.

Other medicines and Dutasteride Teva

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Some medicines can interact with Dutasteride Teva and increase the risk of side-effects. These medicines include:

• verapamil or diltiazem (for high blood pressure),
• ritonavir or indinavir (for HIV),
• itraconazole or ketaconazole (for fungal infections),
• nefazodone (an antidepressant),
• alpha-blockers (for enlarged prostate or high blood pressure).

Inform your doctor if you are taking any of these medicines. Your dose of Dutasteride Teva may need to be reduced.

Dutasteride Teva with food and drink

Dutasteride Teva can be taken with or without food.

Pregnancy and breast-feeding

Women who are pregnant (or may be) must avoid any contact with leaking capsules. Dutasteride is absorbed through the skin and can affect the normal development of a male baby. This is a particular risk in the first 16 weeks of pregnancy.

Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking Dutasteride Teva. If your partner is or may be pregnant, you must avoid exposing her to your semen.

Dutasteride Teva has been shown to reduce sperm count, semen volume and sperm movement. Therefore male fertility may be reduced.

Contact your doctor immediately if a pregnant woman has come into contact with dutasteride.

REG0048149

Version 2.5

Approved

Page 3 of 7

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Dutasteride Teva is unlikely to affect your ability to drive or operate machinery.

Always take Dutasteride Teva exactly as your doctor has told you. If you do not take it regularly the monitoring of your PSA levels may be affected. You should check with your doctor or pharmacist if you are not sure.

The usual dose is one capsule (0.5 mg) taken once a day. Swallow the capsules whole with water. Do not chew or break open the capsule. Contact with the contents of the capsules may make your mouth or throat sore.

Dutasteride Teva is a long term treatment. Some men notice an early improvement in their symptoms. However, others may need to take Dutasteride Teva for 6 months or more before it begins to have an effect. Keep taking Dutasteride Teva for as long as your doctor tells you.

If you take more Dutasteride Teva than you should

Contact your doctor or pharmacist for advice if you take too many Dutasteride Teva capsules.

If you forget to take Dutasteride Teva

Do not take a double dose to make up for a forgotten capsule. Just take your next dose at the usual time and then continue as earlier

If you stop taking Dutasteride Teva

Don’t stop taking Dutasteride Teva without talking to your doctor first It may take up to 6 months or more for you to notice an effect.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Dutasteride Teva can cause side effects, although not everybody gets them.

Very rare allergic reaction

The signs of allergic reactions can include:

• skin rash (which can be itchy),
• hives (like a nettle rash),
• swelling of the eyelids, face, lips, arms or legs.

Stop using Dutasteride Teva and contact your doctor immediately if you get any of these symptoms.

Common side effects

These may affect up to 1 in 10 men using Dutasteride Teva:

• impotence (not able to achieve or maintain an erection),
• decreased sex drive (libido),
• difficulty with ejaculation,
• breast enlargement or tenderness (gynecomastia),
• dizziness when taken with tamsulosin.

Uncommon side effects

These may affect up to 1 in 100 men taking Dutasteride Teva

REG0048149

Version 2.5

Approved

Page 4 of 7

-heart failure (heart becomes less efficient at pumping blood around the body. You may have symptoms such as shortness of breath, extreme tiredness and swelling in your ankles and legs).

- hair loss (usually from the body) or hair growth

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Dutasteride Teva after the expiry date which is stated on the outer carton and blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C. Store in the original package in order to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Dutasteride Teva contains

• The active substance is dutasteride
• Each soft capsule contains 0.5 mg of dutasteride
• The other ingredients are butylhydroxytoluene (E321) and glycerol monocaprylocaprate, medium chain triglycerides, liquid paraffin, purified water.
• The capsule shell contains gelatin (160 Bloom), glycerol (E422), titanium dioxide (E171) and yellow Iron Oxide (E172).

What Dutasteride Teva looks like and contents of the pack

Dutasteride Teva 0.5 mg soft capsules are size 6, oblong, yellow, opaque capsules filled with a clear to yellow solution, without printing.

They are available in packs of 10, 28, 30, 50, 60, 90 and 100.

10 (blisters of : 2 x 5 capsules, 1 x 10 capsules) /carton

28 (blisters of : 2 x 14 capsules, 4 x 7 capsules, 7 x 4 capsules)/carton 30 (blisters of: 3 x 10 capsules, 6 x 5 capsules) /carton

50 (blisters of : 5 x 10 capsules, 10 x 5 capsules)/carton 60 (blisters of : 6 x 10 capsules, 12 x 5 capsules)/carton 90 (blisters of : 9 x 10 capsules, 18 x 5 capsules) /carton 100 (blisters of: 10 x 10 capsules 5 x 20 capsules)/carton

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Teva Nederland B.V. Swensweg 5, 2031 GA Haarlem

REG0048149

Version 2.5

Approved

Page 5 of 7

Fabrikanten

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen, Hongarije

TEVA UK Ltd

Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, Verenigd Koninkrijk

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

TEVA Santé

Rue Bellocier, 89100 Sens, Frankrijk

Teva Czech Industries s.r.o.,

Ostravska 29, c.p. 305, 74770 Opava-Komarov, Tsjechie

Merckle GmbH, Ludwig-Merckle-Straße 3, 89143 Blaubeuren, Duitsland

CT Arzneimittel GmbH, Graf-Arco-Stra8e 3, 89079 Ulm, Duitsland

HBM Pharma s.r.o, Sklabinská 30, 036 80 Martin, Slowakije

Ingeschreven in het register onder:

RVG 113598

This medicinal product is authorised in the Member States of the EEA under the following names:

Bulgaria, Estonia, Finland, Malta: Dutasteride Teva 0.5mg soft gel capsules

Ireland: Dutasteride Teva 0.5mg Soft Capsules

Denmark, Poland: Dutasteride Teva

Finland: Dutasteride Teva 0.5 mg pehmeä kapseli

Lithania: Dutasteride Teva 0.5 mg minkštos kapsulės

Latvia: Dutasteride Teva 0.5 mg mīkstās kapsulas

Portugal: Dutasterida Teva

Spain: Dutasterida Teva 0.5 mg cápsulas blandas EFG

Romania: Dutasteridă Teva 0.5 mg capsule moi

Slovenia: Dutasterid Teva 0.5 mg mehke kapsule

Slovakia: Dutasterid Teva 0.5 mg

Iceland: Dutasteride Teva

Germany: Dutasterid AbZ 0,5 mg Weichkapseln

Belgium: Dutasteride Teva 0,5 mg capsule, zacht

France: Dutasteride Teva 0.5 mg capsule molle

Italy: Dutasteride Teva

Netherlands: Dutasteride Teva 0,5 mg, zachte capsules

United Kingdom: Dutasteride 0.5 mg Soft Capsules

Deze bijsluiter is voor het laatst goedgekeurd in oktober 2013